This study is aimed to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the treatment of relapsed or refractory multiple myeloma
This is a study to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the treatment of relapsed or refractory multiple myeloma. The Main research objectives: To evaluate the safety and efficacy of BCMA CAR-T in patients with relapsed or refractory multiple myeloma The Secondary research objectives: To investigate the cytokinetic characteristics of BCMA CAR-T in patients with relapsed or refractory multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Biological: BCMA CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
He bei Yan da Lu dao pei Hospital
Yanda, Hebei, China
RECRUITINGBeiJing Ludaopei Hospital
Beijing, Yizhuang, China
RECRUITINGSafety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within first one month after BCMA CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Time frame: First month post CAR-T cells infusion
Efficacy: Overall Remission Rate (ORR)
Overall Remission Rate (ORR) including partial remission and complete
Time frame: 3 months post CAR-T cells infusion
Efficacy:duration of response (DOR)
duration of response (DOR)
Time frame: 24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)
progression-free survival (PFS) time
Time frame: 24 months post CAR-T cells infusion
CAR-T proliferation
the copy number of BCMA CAR- T cells in the genomes of PBMC by qPCR method and percentage of BCMA CAR- T cells measured by flow cytometry method
Time frame: 3 months post CAR-T cells infusion
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
Time frame: First month post CAR-T cells infusion
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